Propofol or Midazolam for Sedation and Early Extubation Following Coronary Artery Bypass Graft Surgery

Coronary Artery Disease Clinical Trial

Official title:

Propofol or Midazolam for Sedation and Early Extubation Following Coronary Artery Bypass Graft Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05290324
• Other study ID #: CPEIC22
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: March 2022
• Source: Chaudhry Pervaiz Elahi Institute of Cardiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Propofol and midazolam are used frequently as sedating agents among patients who undergo coronary artery bypass graft surgery but no study in Pakistan has been done to compare their effectiveness aiming early extubation.

Description:

Propofol is an intra lipid and alkali phenol chemically it is unrelated to sedative agents or anaesthetic. Midazolam is a banzodiazepen. Most of its properties are similar to diazepam. It is a common practice to use sedatives to provide comfort and decrease "ventilator-asynchrony" in critically ill patients that may require prolonged invasive mechanical ventilation. The other reason to employ sedatives is to reduce the anxiety associated with the inaviseve procedures routinely conducted in the ICU.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 20 Years

Eligibility

Inclusion Criteria:

• Patients of American Society of Anesthesiologists (ASA) III who were selected for coronary artery bypass graft surgery.

Exclusion Criteria:

• History of any psychiatric disease.
• Using antidepressants
• Alcohol abusers
• Obese
• Pregnant women

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Drug:
• Midazolam
Midazolam infusion will be given after the surgery as 0.25 mg/kg/min.

Locations

Country	Name	City	State
Pakistan	Ch. Pervaiz Elahi Institute of Cardiology	Multan	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Chaudhry Pervaiz Elahi Institute of Cardiology

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of post-surgery sedation	Duration of post-surgery sedation following cardiac surgery	Time in minutes calculated from end of surgery to the time of awakening up to 24 hours in both study groups
Primary	Time taken to post-surgery extubation	Time taken from the end of cardiac surgery to post-surgery extubation	Time taken in minutes from the end of the cardiac surgery to post-surgery extubation up to 1 week duration in both study groups